Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017375271

FEI Number

3017375271

Entity Name

Scandinavian Medical Solutions A/S

City/State/Country

Aalborg Nordjylland, DK

Establishment Address

Gasvaerksvej 48, 1st Floor, Aalborg Nordjylland 9000, DK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Scandinavian Medical Solutions A/S (Owner Number: 10077435)

Owner / Operator Contact Address

Gasvaerksvej 48, 1st Floor, Aalborg, DK-NOTA 9000, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151486

PMA Number

N/A

All Registered Proprietary Names

GE Discovery IQ5R Selenia Dimensions Siemens TxRx 15Ch Knee Coil 3T, 10606829 GE Revolution CT Apec Edition 512 Siemens Verio 3T GE MR 450W GE Optima CT660 Siemens CT Force Siemens Biograph Horizon Siemens Inspiration Biograph mCT 20 Flow

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-12-23
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2025-02-14
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-11-17
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-11-17
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-11-17
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2021-03-29
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-03-29
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-02-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-02-14
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-12-08
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2020-12-08
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-04-04
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-02-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-01-28
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2026-01-28
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2026-01-28
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2022-12-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-12-15
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2022-12-15
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2022-01-24
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-03-21
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2020-08-27
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-12-11
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-06-01
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-04-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-11-04
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-07-01
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2024-03-05
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-03-05
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2024-03-05
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-03-27
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-07-01
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-07-01
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2025-04-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-06-21
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2025-04-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-04-03

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Scandinavian Medical Solutions A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033956	Is2 Research, Inc.	MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)	2004-01-20
K923309	GE Medical Systems	ARGUS PET SYSTEM	1992-09-29
K101768	Miegmbh	MIE SCINTRON GAMMA CAMERA SYSTEMS	2010-10-05
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2016	Toshiba American Medical Systems Inc	2	Celesteion PCA-9000A/2 PET/CT System
Z-0012-05	General Electric Med Systems LLC	2	Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Z-0013-2007	Philips Medical Systems (Cleveland) Inc	2	Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.
Z-0014-2007	Philips Medical Systems (Cleveland) Inc	2	Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.
Z-0024-2014	GE Healthcare, LLC	2	GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.

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3011950073	United Imaging Healthcare North America, Inc	Houston, TX, US
3008962177	GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.	Valencia, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017375271. Last updated year: 2026. Please use registration number 3017375271 when referencing this establishment in official correspondence.